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Neoadjuvant Chemotherapy in Non Small Cell Lung Cancer (NSCLC) Stages IB, IIA, IIB, and IIIA/T3

Information source: Rigshospitalet, Denmark
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-small Cell Lung Cancer

Intervention: Carboplatin and Paclitaxel (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Rigshospitalet, Denmark

Official(s) and/or principal investigator(s):
Jens B. Sorensen, MD, Study Chair, Affiliation: Dept. Oncology, Rigshospitalet

Summary

Randomised trial of chemotherapy or not before surgery in early resectable stages of NSCLC (IB, IIA, IIB, and IIIA/N2).

Clinical Details

Official title: Neoadjuvant Chemotherapy in Resectable NSCLC Stages IB, IIA, IIB, and IIIA/T3 But Not IIIA/N2

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Survival

Secondary outcome:

Time to progression

Complete resection rate

Detailed description: Randomisation between 3 courses of neoadjuvant Carboplatin plus Paclitaxel or no chemotherapy before surgery.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- NSCLC

- Stages IB, IIA, IIB, IIIA/T3

- Lung function test allowing surgery

- Age 18-75 years

Exclusion Criteria:

- Poor lung function

- Performance status 3-4

- Mediastinal lymph node involvement

Locations and Contacts

Dept. Oncology, Rigshospitalet, Copenhagen 2100, Denmark
Additional Information

Starting date: January 1998
Last updated: September 17, 2009

Page last updated: August 23, 2015

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